Can a company oppose the publication of a sanction imposed on it?
Order of the Supreme Court of 16 October 2024
Capsulas Nº 258
Background The Law on Guarantees and Rational Use of Medicines and Health Products establishes that sanctions for serious and very serious infringements must be published in the Official State or regional gazette. However, there is no obligation to publish minor sanctions. In recent years, some individuals have requested access to minor sanctions imposed on pharmaceutical... Read More
More options for whistleblowers
Royal Decree 1101/2024 of 29 October approving the Statute of the Independent Authority for the Protection of Whistleblowers
Capsulas Nº 258
On 31 October, Royal Decree 1101/2024 came into force, creating the Independent Authority for the Protection of Whistleblowers (“AIPI”, by its Spanish acronym) and approving its statute. The creation of this body had been expected since the approval of Law 2/2023 on the protection of persons who report breaches of the law and on fight... Read More
Purchases of products outside the Law on Public Sector Contracts
Regarding the Judgment of the High Court of Justice of Andalusia of 21 October 2024
Capsulas Nº 258
The reality of direct purchasing In its assessment of public spending in 2019, the Independent Authority for Fiscal Responsibility (“AIREF”, by its Spanish acronym) said that 68.6% of medicinal product purchases in Spain were “non-standardised”. This category included purchases via minor contracts and direct purchases through commercial offers outside the Law on Public Sector Contracts... Read More
Criteria to be considered in the advertising of medical devices
Pending the new Royal Decree on this matter, it is advisable to rely on the criteria set out in the guidelines approved at a regional level
Capsulas Nº 258
Almost a year has passed since the Ministry of Health launched a public consultation on the draft royal decree on the advertising of medical devices. Until this new regulation is approved, it is worth paying attention to the criteria applied by the regional authorities in relation to the advertising of medical devices addressed to the... Read More
New rules to encourage out-of-court settlement of civil and commercial disputes
Organic Law 1/2025, of 2 January, on measures for the efficiency of the Public Justice Service
Capsulas Nº 258
Obligation to negotiate The recent Organic Law 1/2025, published on 3 January, aims to improve the efficiency of the courts. To this end, various measures have been adopted, including those that promote the out-of-court resolution of civil and commercial disputes. For instance, as of 3 April 2025, the use of appropriate alternative dispute resolution methods... Read More
Retos y oportunidades de la Inteligencia Artificial
El Global
La semana pasada tuve el privilegio y el placer de participar en la jornada sobre “Innovación Digital en Salud: transformación para un sistema eficiente y accesible” celebrada en el Senado, organizada por la Universidad Internacional Menéndez Pelayo (UIMP) con la colaboración de Novartis. Bajo la moderación de Mireia Castro (Directora Jurídica de Novartis España), participé... Read More
Nuevas medidas para evitar conflictos de intereses en la evaluación de medicamentos
El Global
La semana pasada, la Agencia Europea de Medicamentos (EMA) publicó la versión actualizada de su Política 0044 en materia de tratamiento de intereses contrapuestos para los miembros de los comités científicos y de sus expertos. En ella se desgranan las situaciones que permiten restringir o excluir la participación de un experto en la actividad de... Read More
La casa por el tejado
El Global
A mediados de diciembre, el Ministerio de Sanidad sacó a consulta pública previa el Proyecto de Real Decreto por el que se regulan los procedimientos de financiación y precio de los medicamentos. El objetivo de esta norma es, entre otros, regular y definir todos aquellos aspectos relacionados con el procedimiento y la metodología aplicables a... Read More
Entre la experiencia y la independencia: lecciones y retos en la gestión de conflictos de interés
CUADERNOS DE DERECHO FARMACÉUTICO Nº 91 OCTOBER-DECEMBER 2024
This article analyzes the recent rulings by the Court of Justice of the European Union in the Aplidin® and Hopveus® cases, which have highlighted the importance of properly managing conflicts of interest in the evaluation of medicinal products. These rulings have prompted the European Commission to review and tighten impartiality criteria in evaluation procedures, especially... Read More
Estrategia de la Industria Farmacéutica
El Global
En 1984 se estrenó en Londres Starlight Express, un musical compuesto por Andrew Lloyd Webber y Richard Stilgoe que narra una competencia de locomotoras (vapor, diésel y eléctrica) para conquistar a Pearl, un vagón de primera clase que sueña con encontrar su “tren ideal”. Más allá de su trama, la obra simboliza el desafío de competir... Read More